DONOR INFECTIOUS DISEASE TESTING
Zika virus RNA polymerase chain reaction on the utility channel
of a commercial nucleic acid testing system
Ashley J. Duits,
and Marco H.G.M. Koppelman
Several countries have implemented
safety strategies to reduce the risk of Zika virus (ZIKV)
transmission through blood transfusion. These strategies
have included nucleic acid amplification testing (NAT) of
blood donations. In this study, a new real-time
polymerase chain reaction (PCR) assay including
internal control for the detection of ZIKV on the cobas
omni Utility Channel (UC) on the cobas 6800 system is
STUDY DESIGN AND METHODS:
and primer/probe concentrations were optimized on the
LightCycler 480 instrument. Optimized conditions were
transferred to the cobas omni UC on the cobas 6800
system. Subsequently, the limit of detection (LOD) in
plasma and urine, genotype inclusivity, specificity, cross-
reactivity, and clinical sensitivity were determined.
The 95% LOD of the ZIKV PCR assay on the
cobas 6800 system was 23.0 IU/mL (95% confidence
interval [CI], 16.5-37.5) in plasma and 24.5 IU/mL (95%
CI, 13.4-92.9) in urine. The assay detected African and
Asian lineages of ZIKV. The specificity was 100%. The
clinical concordance between the newly developed ZIKV
PCR assay and the investigational Roche cobas Zika
NAT test was 83% (24/29).
We developed a sensitive ZIKV PCR
assay on the cobas omni UC on the cobas 6800 system.
The assay can be used for large-scale screening of blood
donations for ZIKV or for testing of blood donors
returning from areas with ZIKV to avoid temporal
deferral. This study also demonstrates that the cobas
omni UC on the cobas 6800 system can be used for in-
house–developed PCR assays.
ika virus (ZIKV) is a flavivirus isolated in 1947
from a rhesus monkey in the Zika forest in
Uganda and was identified in humans in 1952.
Approximately 80% of the ZIKV infections
remain asymptomatic or subclinical.
The symptoms are
usually nonspecific and include fever, rash, musculoskele-
tal pain, headache, and conjunctivitis.
ZIKV infection of
the central nervous system can present as meningoen-
cephalitis. A major concern is the association of ZIKV
infection with Guillain-Barr
e syndrome in adults and
microcephaly and other neurologic manifestations in
fetuses of infected mothers.
ZIKV is primarily transmitted to humans by the bite
of an infected Aedes species mosquito (Ae. aegypti and Ae.
Other transmission routes are possible,
including sexual, mother-to-child, and transfusion-
The potential of ZIKV transmis-
sion through blood transfusion was demonstrated during
the 2013 to 2014 outbreak in French Polynesia when 2.8%
ABBREVIATIONS: CHIKV 5 chikungunya virus; Ct 5 cycle
threshold; DENV 5 dengue virus; IC 5 internal control;
IS 5 international standard; LOD 5 limit of detection;
MMx-R2 5 master mix reagent 2; UC 5 Utility Channel;
WNV 5 West Nile virus; ZIKV 5 Zika virus.
Sanquin Blood Supply Foundation, National
Screening Laboratory of Sanquin (NSS), Amsterdam, the
Biomedical & Health Research Institute,
Willemstad, Curac¸ao; and the
Red Cross Blood Bank
Address reprint requests to: Dr M.H.G.M. Koppelman, San-
quin Blood Supply Foundation, National Screening Laboratory
of Sanquin (NSS), Plesmanlaan 125, 1066 CX Amsterdam, the
Netherlands; e-mail: firstname.lastname@example.org.
This study was supported by Roche Molecular Diagnostics
(Provided UC reagents)
Received for publication March 15, 2017; revision received
October 25, 2017; and accepted November 11, 2017.
Volume 58, March 2018 TRANSFUSION 641